A Study of LY2189265 and Sitagliptin in Participants With Type 2 Diabetes

What Was Tested

In this phase 1 trial, researchers set out to test Dulaglutide.

The purpose of this study is to study the effect of LY2189265 on how the body absorbs and processes a Type 2 Diabetes Mellitus (T2DM) drug (sitagliptin) and how sitagliptin affects LY2189265 when they are taken together.

The duration of participation in this study is expected to be approximately 61 days.

The study requires 2 clinic confinements (one of 2 nights and one of 19 nights duration).

It had two arms (groups): LY2189265, Sitagliptin + LY2189265 (experimental) and Sitagliptin + LY2189265, LY2189265 (experimental).

The registry classes the interventions as biological and drug.

Who Took Part

29 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Are males or females, diagnosed with T2DM (Type 2 Diabetes Mellitus) for ≥3 months prior to screening. Condom with spermicidal agent. Male participant sterilization. True abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable). Have a body mass index (BMI) of between 23.0 and 40.0 kilograms/meter squared (kg/m\^2), inclusive, at the time of screening.

The full record lists 15 inclusion and 23 exclusion criteria; among the exclusions: have known allergies to glucagon-like-peptide 1 (glp-1)-related compounds, including ly2189265 or to sitagliptin-related compounds or any components of either formulation; have taken insulin, chlorpropamide, or alpha-glucosidase inhibitors within 30 days prior to screening; have had 2 or more episodes of severe hypoglycemia within the last 6 months prior to screening.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

Each person switched between Dulaglutide and the comparison at some point, usually with a gap in between.

Being open-label, the Dulaglutide study did not mask who received what.

It started in 2011-08 with completion listed for 2012-04.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 29 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Dulaglutide compound page, all human trials.